Medical devices

ETSI is developing a number of standards for medical devices that are implanted in the human body, and communicate to an external device to allow them to be adjusted in situ by qualified medical practitioners.

On a broader theme, ETSI is also involved in creating an eHealth work programme for standards in the Information and Communications Technology (ICT) sector that touch health issues.

Initial ETSI work has concentrated on defining the need for radio spectrum for medical devices, in order to help radio regulators find harmonized frequencies within the European Community.

ETSI has also developed Harmonised Standards for some device types, enabling them to be placed on the European market.

Radio Spectrum - System Reference Documents for several medical applications are developed within the Radio Matters working group of ETSI technical committee Electromagnetic Compatibility and Radio Spectrum Matters (ERM), and communicated to the CEPT as the basis of European radio frequency harmonization measures.

eHealth standards are studies which take into consideration ETSI standards having an influence on eHealth and future needs for the ICT health sector.

Radio Spectrum Standards

ETSI has developed System Reference Documents for the following medical applications:

Harmonised Standards

All radio equipment placed on the European market is required to comply with the Radio Equipment Directive (RED). This sets requirements on safety, ElectroMagnetic Compatibility (EMC) and correct use of the radio spectrum to avoid harmful interference.

Standards related to safety for medical devices are available from CENELEC.EMC standards are developed and maintained by the EMC working group of ETSI technical committee Electromagnetic Compatibility and Radio Spectrum Matters (ERM).

Land Mobile Service; Radio Equipment for use in a Paging Service operating within the frequency range 25 MHz - 470 MHz; Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU